HOW TO BECOME A
CODEX HERO
Federation of
European Specialty
Food Ingredients
Industry
www.elc-eu.org
As the world continues its path towards increased
globalization, also the food industry adjusts to the new
realities and challenges. At ELC, we are observing
all around the world an ever-growing demand for
innovative, safe and convenient food ingredient solutions.
The European specialty food ingredients sector therefore
needs to invest time and resources to participate in
international regulatory fora like Codex Alimentarius
Committees. As ELC President, I am very pleased with
the achievements of our dedicated working group, which
has built strong expertise on Codex related issues to the
benefit of all ELC members. This document is just one
example of the value that our federation brings to assist
you to be successful on the international arena.
Franck Monmont
ELC President
Cargill
WHAT IS THE CODEX?
The Codex Alimentarius, or the food code,
has become the global reference point for
the international food trade. While being
recommendations for voluntary application
by member countries, Codex standards
serve in many cases as a basis for national
legislation. The reference made to Codex
food safety standards in the World Trade
Organization’s Agreement on Sanitary and
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| How to become a Codex hero
Phytosanitary measures (SPS Agreement)
means that the Codex has far reaching
implications for resolving trade disputes.
The Codex Committee on Food Additives
(CCFA) is the Committee in charge of the
standard related to food additives, based
on safety assessments performed by the
FAO/WHO Joint Expert Committee on Food
Additives (JECFA).
CODEX, A SYNONYM
FOR COMPLEX? MAYBE…
BUT ELC IS HERE TO
HELP YOU OUT
Innovation is crucial for industry. As a
result of innovation, new food additives
are launched and require international
approval for use, or an existing additive
requires an extension of use or a new
technical application is identified. These
are typical situations in which an innovation
producing company finds itself in. In this
document we address these three aspects
from a regulatory/lobby perspective.
Based on its solid experience, our working
group dedicated to the Codex Committee
on Food Additives (CCFA) has developed
some recommendations. These might be
helpful if you wish to have new provisions
included in the General Standard for Food
Additives (GSFA), a substance evaluated by
the Joint FAO/WHO Expert Committee on
Food Additives (JECFA), or the International
Numbering System updated according to
the latest technological developments.
This document was prepared to guide you
through the Codex maze. Of course, each
case is special and a careful analysis of the
Codex history of the substance at stake, its
evaluation and status in key jurisdictions as
well as of Codex Guidelines are paramount
before entering the CCFA arena.
FOLLOW THESE INSTRUCTIONS
CAREFULLY AND YOU WILL BE
ON TRACK FOR SUCCESS!
We strongly recommend you to join our
working group and contact us if you have
not done so already.
HAPPY READING
AND GOOD LUCK.
How to become a Codex hero |
3
ACRONYMS AND DEFINITIONS
4
ADI
Acceptable Daily Intake
CAC
Codex Alimentarius Commission
CCFA
Codex Committee on Food Additives
CCNFSDU
Codex Committee on Nutrition and Foods for Special Dietary Uses
CL
Circular Letter
CRD
Conference Room Document
CS
Codex Standard
CTAs
Chemical and technical assessments of food additives
EFSA
European Food Safety Authority
e-WG
Electronic Working Groups
FAO
Food and Agriculture Organization of the United Nations
FIA Committee
Food Improvement Agents Committee of the ELC
GL
General Guidelines
GMP
Good Manufacturing Practice
GSFA
General Standard for Food Additives
INF 01 document
A Working document for information and support to the discussion
on the GSFA, which gives the status of each additive in the Codex
procedure (either in the step process or already adopted)
INF 02 document
An information document compiling all food additive provisions of
Codex Commodity Standards
INS
International Numbering System
JECFA
Joint FAO/WHO Expert Committee on Food Additives
WG
Working Group
WHO
World Health Organization
| How to become a Codex hero
A TYPICAL CODEX YEAR
ELC delegation
at CCFA:
Defends ELC
position as
detailed in the
Masterfile
ELC WG CCFA:
Sends final comments
for endorsement to
FIA committee >
ELC Masterfile
Delegation:
Feedbacks to WG CCFA
and FIA Committee
ELC WG CCFA:
Prepares ELC’s
comments
and positions
ELC secretariat:
Centralises and
receives all relevant
Codex communications
CCFA eWGs
subscriptions
+ two rounds
of consultations*
*ELC typically participates
in about five eWGs
How to become a Codex hero |
5
WHAT IS THE GSFA?
The General Standard for Food Additives is the horizontal standard that is intended
to include food additives provisions for standardised and non-standardised foods
in the Codex Alimentarius. It is continuously under development.
HOW TO GET A NEW GSFA ENTRY
A FEW THINGS TO BE
CHECKED BEFOREHAND...
Was your additive already
evaluated by the Joint FAO/
WHO Expert Committee on
Food Additives (JECFA)?
The new entries are already
“parked” in GSFA at step
process. Seek further
guidance with ELC to
accelerate procedure.
Check Table Two of the GSFA
(CODEX STAN 192-1995):
Are other additives
(especially with similar
technological purposes)
already permitted in food
categories you have in mind?
Apply for a JECFA evaluation. Preliminary step is
to have your additive mentioned in the Priority list
of substances proposed for evaluation by JECFA
(via a different procedure). See page 8.
NO

YES

Does your additive have an
International Numbering
System (INS) number?
YES

Check the INF 01 document:
Are the new provisions you
have in mind already listed
in GSFA at step process?
NO

YES

GSFA in Useful Links.
NO

Check INS list (Section 3
of CAC/GL 36-1989):
Is the technological purpose
you have in mind already
mentioned for your additive
in INS list?
*The INF 01 and INF 02 documents are standing documents updated on an annual basis.
| How to become a Codex hero
NO

YES

INS list in Useful Links.
For uses in standardized foods regulated by active Committees,
CCFA may decide to forward them to relevant Committees when your
provisions are discussed. We would also invite you to monitor the work
of the Alignment working group (co-chaired by Australia and the USA).
Apply for inclusion of this
new additive into INS list
(via a different procedure.)
See page 10.
YES

FA/48 INF/01 document*
in Useful Links.
Prepare sound and strong
technical justification for its
inclusion into the GSFA.
6
NO

You will first have to apply
for a modification of INS list
(via a different procedure).
See page 10.
Check Annex C to GSFA and
INF 02 document: Are the
food categories you have in
mind covered by Commodity
Standards? Are the relevant
Codex Committees active?
GSFA and INF/02 document*
in Useful Links.
YES

NO

Congratulations, you can
consider applying for a new
entry into the GSFA!
FILLING IN THE STANDING
CIRCULAR LETTER (CL)
ELC members are also recommended to fill in the
Instructions Document.
Always use the form provided in Annex I to the
Standing Circular Letter (CL) entitled “Request for
proposals for new and/or revision of food additive
provision of the GSFA” (this year, 2016, it’s reference
is CL-2016/8-FA, see Useful Links).
IDENTITY OF THE ADDITIVE
• Name, INS number and Functional class.
PROPOSED USE(S) OF THE FOOD ADDITIVE
• List all the (sub-)categories in which the additive
is intended to be used.
PROCEDURE
AND FOLLOW-UP
Liaise with Codex members and observers
including relevant food sectors for support
at CCFA session.
SUBMISSION
ELC members are also recommended to fill in the
Instructions Document.
1 Send your draft submission (CL and ELC
instructions) in a Word format to ELC secretariat
latest end November. Your draft request will be
circulated to ELC members (anonymously) in
order to be submitted on behalf of the association.
• Check the ADI first (in the JECFA Monograph).
Liaise with relevant food sectors, to get
their support if they attend the GSFA WG and
CCFA meetings.
• Numerical ADI? Are proposed uses in line with
ADI? Provide maximum use levels.
2 After endorsement, ELC forwards your request to
the Codex and CCFA secretariats.
• ADI “not specified” > Table 3 of the
GSFA inclusion.
3 Your request will appear in a CCFA Working
Document for discussion.
DISCUSSION
JECFA EVALUATION
• Year of the evaluation, JECFA session,
Monograph and ADI (numerical or
“not specified”).
JUSTIFICATION
• Use of the additive has an advantage?
• Does not present an appreciable health risk
to consumers?
- Dietary intake assessment.
• Does not mislead consumer?
- You may refer to labelling requirements.
Please note that these requirements may not
be applicable for fresh foods.
- Critical examples can be: the use of additives
on fresh/unprocessed products such as fresh
fruit cuts, or the use of colours in oils.
• Has a technological function?
4 First discussion during physical GSFA Working
Group (WG). Request correctly filed? Sound
technical justification? Support for adopting the
proposal into GSFA step process?
Make sure you are present in the meeting room
when your request is discussed.
5 If physical GSFA WG recommends the Committee
to endorse it, your request will be presented in
plenary for endorsement in Conference Room
Document 2 (CRD 2).
COMMITTEE DECISION AND NEXT STEPS
6 If the Committee endorses your request,
the provision(s) will be forwarded to Codex
Alimentarius Commission for inclusion into the
GSFA at step 2.
7 Step 2 is the early stage of the adoption procedure
(there are 8 steps in the Codex Procedure).
8 Discussions on your provision(s) will resume
when they are brought back on the agenda of the
electronic GSFA WG (chaired by USA).
How to become a Codex hero |
7
WHAT IS THE JECFA?
The Joint FAO/WHO Expert Committee on Food Additives (JECFA) is an international
expert scientific committee that is administered jointly by the Food and Agriculture
Organization of the United Nations (FAO) and the World Health Organization (WHO).
HOW TO INCLUDE YOUR SUBSTANCE
IN THE JECFA PRIORITY LIST
FEW THINGS TO BE
A
CHECKED BEFOREHAND...
Is your substance ONLY
within the mandate of the
Codex Committee on Food
Additives (CCFA)?
i.e. additives and processing
aids, including food enzymes.
Is your request related to an
additive use in infant foods
and infant formula?
Ask CCNFSDU first to
confirm technological need
for use of the additive in
infant formula and whether
it is advisable for JECFA to
do a safety assessment.
NO

YES

NO

YES

If your substance is a nutrient, the Codex
Committee on Nutrition and Foods for Special
Dietary Uses (CCNFSDU) is responsible, not CCFA.
If your substance concerns a use in a food which
falls in the remit of a Commodity Committee,
that Committee is not involved in the Priority
List setting. However, it needs to be liaised
with at a later stage. Please consult ELC for
further guidance.
Data already available?
Will they be available by
the end the same year
of the CCFA session
(indicative deadline)?
NO

YES

Evaluation request also
submitted at national or
regional level (i.e. EU)?
Is it related to an already
existing provision in a
member country or region?
NO

YES

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| How to become a Codex hero
If the data is not available by
JECFA deadline, in-session
working group at CCFA
will not recommend your
additive be added to the
Priority List.
Make sure you have the
support of a member
country/delegation,
otherwise your request will
not be carried.
Congratulations, you can
consider applying for the
inclusion of your substance
into the JECFA Priority List!
FILLING IN THE STANDING CIRCULAR LETTER (CL)
Always use the form provided in Annex 2 to the CL entitled “Request for information and comments on the priority list
of substances proposed for evaluation by JECFA” (this year, 2016, its reference is CL-2016/13-FA, see Useful Links).
QUESTION(S) TO BE ANSWERED BY JECFA
Clearly indicate the nature of the request(s)
(e.g. safety “assessment and establishment of
specifications” or “revision of specifications”).
HAS THE MANUFACTURER MADE
A COMMITMENT TO PROVIDE DATA?
The data MUST be available by a given deadline
(i.e. December the same year of the CCFA session).
JUSTIFICATION FOR USE
Clearly indicate the purpose of use. This must be
a food additive use consistent with the Codex food
additive definition.
LIST OF DATA AVAILABLE
Tick data available by a check mark (√) and give
headlines of the data available. Identify other types
of toxicological data under point 9(iv) “Other data”
and any other information under “Other information”
(as necessary/identified).
DATE ON WHICH DATA COULD
BE SUBMITTED TO JECFA
If the additive is on JECFA’s ‘call for data’ and the data
are not submitted by the deadline, the request will
need to be re-submitted to the CCFA in response to
the next CL.
PROCEDURE AND FOLLOW-UP
SUBMISSION
1 Send your draft submission in a Word format to
ELC secretariat latest end November. Your draft
request will be circulated to ELC members to be
submitted on behalf of the association.
2 After endorsement, ELC forwards your request to
Codex and CCFA secretariats.
3 Your request will appear in a CCFA document
for discussion.
DISCUSSION
4 Discussion by in-session working group on
proposals for the priority list of substances
proposed for evaluation by JECFA, chaired
by Canada.
Make sure you are present in the meeting room
when your submission is discussed.
- First discussions on substances that were
added to Priority List in previous year.
Substances carried-over from the previous year
are “high priority”.
- Then, in-session working group considers the
new requests for additions of substances to
the Priority List.
- In both cases, the “sponsor” (member country)
must be present to support the request and
confirm that the data are/will be available.
5 If the in-session working group recommends the
Committee to endorse your submission, it will
appear in draft list presented to the plenary in a
Conference Room Document (CRD).
COMMITTEE DECISION AND NEXT STEPS
6 The Committee endorses Priority List.
7 JECFA issues a “call for data” on the basis of the
Priority List (generally in August, with a deadline
in December). If your substance appears in
the call, your data must be sent to the JECFA
secretariat (the email addresses are mentioned
in the call for data).
The inclusion of substances into the ‘calls for
data’ is JECFA’s own prerogative.
8 JECFA experts discuss a number of additives
mentioned in its call for data, provided that
they had received sufficient data (in June the
following year).
Due to heavy workload, there might be a
bottleneck in the coming years.
9 JECFA output
- Chemical and technical assessment of the
food additive (CTA).
- Specifications.
- Safety evaluation.
- Summary report and report: the electronic
summary containing only basic conclusions.
The report consists of summary of relevant
information for evaluation and conclusion,
including intake estimates.
10 If your substance has been assessed by JECFA,
a short summary about it will be tabled to the
next CCFA session, which in turn takes further
action as required.
How to become a Codex hero |
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WHAT IS THE INS?
The International Numbering System for Food Additives (INS) is
intended as a harmonised list for food additives as an alternative
to the use of the specific name, which may be lengthy.
HOW TO MODIFY THE INS LIST
(CAC/GL 36-1989)
INS list in Useful Links
A FEW THINGS TO BE
CHECKED BEFOREHAND...
Is your request related
to a new or additional
technological purpose?
Is the technological
purpose you have in mind
already mentioned in the
JECFA Monograph of your
additive (under the heading
“functional uses”)?
NO

YES

YES

NO

Other arguments can
be brought forward (i.e.
Evidence of use for the
technological purpose
proposed; reference
to a Codex Committee
Standard with relevant
provisions etc.). Consult
the delegations of the
member countries
where your additive is
used with this specific
technological purpose.
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| How to become a Codex hero
NO

Is your request related
to modification of an
existing INS name or INS
number purpose?
NO

Check Section 2 of CAC/GL
36-1989. Is the technological
purpose you have in mind
also linked to the functional
class(es) to which your
additive belongs?
YES

INS list in Useful Links.
You can apply but note that
there might be a need to
also amend Section 2 of
CAC/GL 36-1989.
YES

If you intend to have an
additive deleted from the
INS list, please liaise not
only with ELC but also with
other global stakeholders
who might use this additive
in i.e. third countries.
Check the “principles
for changes/additional
to Section 3 of CAC/GL
36-1989” (in Annex I to
the Standing Circular)
and consult ELC for
further guidance.
INS list in Useful Links.
Congratulations, you can
consider applying for a
revision of the INS list!
FILLING IN THE STANDING
CIRCULAR LETTER (CL)
• Before filling in the template provided in the
CL, ask the ELC to register for the electronic
working group in charge of the INS, which is
chaired by Iran.
• Always use the template provided in
Annex 2 to the CL entitled “Request for
proposals for change and/or addition
to Section 3 of the Class Name and
International Numbering System for
Food Additives (CAC/GL 36-1989)” (this
year, 2016, its reference is CL-2016/7-FA,
see Useful Links).
- Provide justifications and arguments
under the “Details” heading.
PROCEDURE
AND FOLLOW-UP
SUBMISSION
1 Send your draft submission in a Word format
to the ELC secretariat by the end of August.
Your draft request will be circulated to ELC
members (anonymously, of course) in order to be
submitted on behalf of the association.
2 After endorsement, ELC forwards your request
to the Codex and CCFA secretariats.
ELECTRONIC WORKING GROUP
(E-WG) CONSULTATION
3 Iran will compile the proposals and prepare a
proposal for circulation and comments at step 3.
This draft document will be sent to the eWG
members for comments.
COMMITTEE DECISION AND NEXT STEPS
4 If no objection is raised on your request by
e-WG members, it will be included into a
CCFA Working Document, open for comments
by members and observers before the next
CCFA session.
5 In-session working group meeting discusses
Working Document and its Addendum. Prepares
recommendations for the plenary.
In-session working group meetings might no
longer be organised for INS issues, due to
reduced workload. To be confirmed.
6 If the Committee endorses your proposal, it
will be forwarded to the Codex Alimentarius
Commission for adoption at step 5/8.
7 If the Commission adopts this recommendation,
the CAC/GL 36-1989 will be amended accordingly.
How to become a Codex hero |
11
IN SUMMARY, TO BECOME A HERO AT CCFA, YOU SHOULD:
• Start by carefully assessing the
situation of your additive
(i.e. has it been assessed by JECFA?
Does it already have an INS number?
Does it have an ADI?...).
• Fill in and strictly follow the forms
provided in Annex to the Codex
Circular Letters.
• Be present at the Codex meetings
if and when your request is on the
agenda of a meeting.
• Liaise with both delegations and
observers to obtain their support.
• Contact the ELC for further guidance
and trust our strong expertise!
USEFUL LINKS
Codex Alimentarius
www.fao.org/fao-who-codexalimentarius
The INF/01 and INF/02 documents are
embedded in the agenda of the CCFA sessions
GSFA
www.fao.org/fao-who-codexalimentarius/
standards/gsfa
FA/48 INF/01 document
http://goo.gl/57Be0C
JECFA
www.fao.org/food/food-safety-quality/
scientific-advice/jecfa
www.who.int/foodsafety/publications/jecfa
List of Standards
www.fao.org/fao-who-codexalimentarius/standards/
list-standards/en/
Codex Procedural Manual
www.fao.org/fao-who-codexalimentarius/
procedures-strategies/procedural-manual
FA/48 INF/02 document
http://goo.gl/RQrLU8
INS list (CAC/GL 36-1989)
http://goo.gl/LuhYXr
CL 2016/7-FA
http://goo.gl/REXbGz
CL-2016/8-FA
http://goo.gl/XeuEQR
CL -2016/13-FA
http://goo.gl/dtR1XS
CONTACTING ELC
ELC secretariat,
Avenue de Tervuren, 13A
B-1040 Brussels
Tel: +32 2 736 53 54
Fax: +32 2 732 34 27
[email protected]
Edited by ELC, July 2016
Federation of
European Specialty
Food Ingredients
Industry
www.elc-eu.org